Post on 13-Mar-2022
transcript
An agency of the European Union
Update of EudraVigilance Operational Plan
Presented by Rodrigo Postigo
Pharmacovigilance platform meeting – 30 October 2020
C lassified as public by the European Medicines Agency
Background
• 1st published following the launch of the new EV
system in November 2017.
• Objective:
• To outline technical as well as operational
activities with anticipated timelines and to
highlight how EV and stakeholders that
interact with the system will be affected.
• To ensure sustainability of EV in support of
the EU pharmacovigilance activities and the
protection of public health.
• The current operational plan covers the period
2020 to 2022.
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Topics
▪ Agency’s identity access
▪ Human and Veterinary EudraVigilance
▪ EV Gateway
▪ Brexit
▪ Mandatory use of ICH-E2B(R3)
▪ ISO IDMP standards
▪ EudraVigilance monitoring by MAHs
▪ ICSR data quality review
▪ Clinical trial regulation
▪ Medical Literature monitoring
▪ GVP VI
▪ EudraVigilance and operation in pharmacovigilance
▪ Training and support
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Integration with the Agency’s identity and access
management (IAM2) project
➢ Integration of the EV Human XCOMP (external
testing system) registration process with the
IAM components completed successfully.
➢ Improvements of the IAM Human components
and the EudraVigilance Human registration to
include the self-management of virtual affiliates
also completed.
➢ Revisions of the EV Human registration manual
and online training in line with the updates are
provided on the EudraVigilance training page.
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The integration of the Human and Veterinary EudraVigilance
system component
➢ Messaging components using a
common platform completed.
➢ adrreports.eu portal upgraded to
include veterinary ADR reports.
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Gateway for the Electronic Standards for the Transfer of
Regulatory Information (ESTRI)
➢ Software upgrades as required by the Agency’s IT strategy, in
particular the implementation of the EDIINT recommendations on
the secure transfer of regulatory information which were updated in
June 2018.
➢ The Agency has contacted all organisations that are currently still
using AS1 for connecting to the EV gateway to inform them of
stopping the use of AS1 towards the end of 2020.
➢ Survey launched on 20th March 2020 for completion by 3rd April
2020, to gather information from our industry end users to inform
future planning of the development of the Gateway for the ESTRI.
(The EV-EWG was consulted on the survey).
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Brexit preparations
➢ Technical adaptations to implement the
relevant changes at the end of the
transitional period.
➢ Discussions about the impact of the
Northern Ireland protocol.
➢ Communications will be issued.
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Agreement on mandatory use of E2B(R3) in EEA
➢ Having considered the PRAC recommendation, the EMA
Management Board announces that the use of:
• the ISO Individual Case Safety Report standard as referred to in Article
26(2)(a) of the Commission Implementing Regulation (EU) No 520/2012
and the modalities on how to use this ISO ICSR standard defined in the
ICH E2B(R3) documentation, and
• the ISO terminology on pharmaceutical dose forms and routes of
administration referred to in Article 25(1)(f) of Commission
Implementing Regulation (EU) No 520/2012,
➢ shall become mandatory as of 30 June 2022 in relation to
reporting obligations to EudraVigilance.
➢ EU Individual Case Safety Report (ICSR) Implementation Guide
currently under revision.
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ISO IDMP standards (Cont)
➢ RMS and OMS went live in June 2017. Any requests for
new or updated referentials or organisations have now to
be pre-registered via the Agency’s SPOR portal.
➢ Further integration steps of RMS and OMS and the
XEVMPD are planned to be implemented as part of the PMS
project.
• The submission process of XEVPRMs will remain unaffected
although it will no longer be possible to create proposed terms
and create/update organisations via XEVPRM.
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ISO IDMP standards (Cont)
➢ SMS Phase 1 went live in June
2019. Substances are no longer
registered in the XEVMPD, instead,
they are being registered in SMS and
then synchronised with the XEVMPD
through a feedback loop.
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ISO IDMP standards (Cont)
➢ As future steps, EMA plans to further deliver SMS and PMS
releases to support EU-wide regulatory activities building
upon the data foundations of RMS and OMS.
➢ As regards ICSR submissions, EudraVigilance and EVDAS,
the main impact expected in relation to the implementation
of the ISO IDMP standards during 2020 to 2022 will refer to
the implementation of the ISO IDMP standard 11239 on
pharmaceutical dose form, units of presentation and routes
of administration.
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EudraVigilance Monitoring and signal management
➢ In Dec 2019, EMA and the Commission agreed to extend the
pilot until the end of 2021 to generate more robust data, after
reviewing the experience gained in the first year of the pilot.
➢ In April 2020, a new availability of eRMRs was launched in the
EVDAS MAHs’ Dashboard to increase the quality of the data
and minimise the number of technical issues.
➢ The MAHs EVDAS Manual was updated to reflect the changes.
➢ Currently reviewing the possibility to increase the number of
users per MAH from 5 to 10.
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EudraVigilance and ICSR data quality review
➢ Detailed guide regarding the EV data management activities by the EMA – published
in January 2020 – currently under revision to update Section 8 ‘Roles and
responsibilities of different stakeholders’.
➢ A monthly publication of spreadsheets providing information on nullified ICSRs and
master cases with associated duplicates to facilitate case reconciliation by NCAs and
MAHs is planned to start in Q4 2020.
➢ The monthly provision of compliance reports for the purpose of the monitoring of
ICSR submission time frames to all EudraVigilance registered organisations is
planned to start in the first half of 2021.
➢ The ICSR data quality review activities will be continued. A new tender for an EMA
service provider will conclude in 2020 and the activity will continue uninterrupted.
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Clinical Trial Regulation
Simplifies the safety reporting by sponsors by facilitating the
submission of:
• Annual Safety Reports (ASRs) directly to the ASR EudraVigilance
Module in the European Clinical Trials Information System (CTIS).
• SUSARs sent directly to the EV Clinical Trial Module (EVCTM), from
where these reports are forwarded to the Member States concerned.
In this context, functionalities that facilitate the forwarding of SUSARs
from EVCTM to the Member States concerned have already been put in
place so they can be “switched on” when the regulation becomes
applicable.
• It is proposed to fix the Go-Live date of CTIS to December 2021,
which means the Clinical Trial Regulation would also enter in
application at that time.
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Clinical Trial Regulation (cont)
➢ Revision of a number of documents in Eudralex
Volume 10.
➢ New documents were prepared to cover new aspects
introduced by the same Regulation.
➢ Until the Clinical Trial Regulation becomes applicable,
sponsors should follow the documents relevant to the
Clinical Trials Directive.
➢ Reference is made to the “Questions & Answers"
Document on the Clinical Trial Regulation, which is
routinely being updated and for which a publication is
planned for in a staggered approach.
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Medical Literature Monitoring (MLM) service
➢ In June 2020, EMA added nine additional active substances
which are being investigated as potential treatments for
COVID-19, and for which there are multiple MAHs.
➢ COVID-19-related search terms were added to the regular
literature searches for six active substance groups
(azithromycin, ciclosporin, dexamethasone, hydrocortisone,
ribavirin and prednisolone) that were already included in the
service.
➢ COVID-19-related literature searches started on 1s t June 2020
in EMBASE, and on 1s t July 2020 in EBSCO.
➢ New tender for an EMA service provider to be launched in
2020.
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GVP Module VI (revision 3)
➢ On 20 November 2019, the Assembly of the International Council
for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH) endorsed the “Concept Paper Post Approval
Safety Data Management: Definition and Standards for Expedited
Reporting E2D (Revision 1)”.
➢ Taking into account that the revision of the E2D guideline will
impact on the provisions set out in the Guideline on good
pharmacovigilance practices (GVP) - Module VI – Collection,
management and submission of reports of suspected adverse
reactions to medicinal products (Rev. 2), a revision of GVP Module
VI will be scheduled following adoption of the harmonised ICH
E2D(R1) guideline (step 4 of the ICH process)
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EudraVigilance and operation of pharmacovigilance
➢ In the context of the operation of EV, technical and procedural aspects
are raised by NCAs, MAHs and sponsors of clinical trials, which require
further discussion and clarification to ensure a coordinated approach
across the EEA.
➢ The pharmacovigilance governance in the EEA provides a forum to discuss
and address emerging issues.
➢ The Pharmacovigilance Business Team which is composed of
pharmacovigilance experts of NCAs and the EMA is meeting on a regular
basis.
➢ Guidance and communications will be issued as needed.
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Stakeholders engagement (e.g.
EV-EWG)
Focus operationsPRAC + (CMDh, CHMP,
CAT)
Focus implementation and operations
Pharmacovigilance Business Team
EU Network PhV Oversight Group
EU Telematics
HMA/EMAMB
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EudraVigilance Expert Working Group
➢ Includes members from the NCAs and representatives of
Industry associations.
➢ During the EMA BCP for relocation the meetings were
significantly reduced.
➢ Members were consulted via written procedure on different
issues.
➢ Virtual meetings were restarted 22nd October 2020.
➢ The updated work-programme and new membership list will
be published by end of 2020.
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Training and support
➢ Face-to-face training courses on the enhanced EV
system were cancelled.
➢ Replaced by virtual events, calendar published
from Sep to Dec 2020.
➢ EVDAS training for Member States scheduled for
Nov 2020 also virtually.
➢ Support webinars have been discontinued.
➢ The e-learning modules remain available.
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